A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product With a Period of Open Safety Assessment in Two Modes of Administration, in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination
详细描述
In the first stage estimate of safety of vaccine after its single administration to the nasal cavity by the drip method or by spray - dispenser during the period of observation in 30 days with the participation of 24 volunteers, divided into 2 groups of 12 people for each method of administration
After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 100 people will receive the study drug and 100 will be a control group of observation - that is, will get a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
This clinical trial on the second stage is designed as a double blind randomized placebo-controlled study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 55 years old.
- •Written informed consent.
- •consent to the use of effective contraceptive methods throughout the study period *
- •* using one of the following methods: abstinence, condoms (male or female with or without spermicide), diaphragm or cervical cap with spermicide, intrauterine device
- •body mass index (BMI) from 18.5 to
- •absence of acute infectious diseases or exacerbation of chronic infections at the time of vaccination and 7 days before vaccination;
- •absence of allergic diseases of a serious degree (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness)
- •absence of strong post-vaccination reactions or post-vaccination complications for previous use of immunobiological drugs;
- •absence of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary and endocrine systems, which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data;
- •negative pregnancy test (for fertile women);
- •negative tests for HIV, hepatitis B and C, syphilis;
- •negative urine test for traces of drugs;
- •negative test for alcohol content in the exhaled air;
- •absence of malignant blood diseases;
- •absence of malignant neoplasms;
- •indicators of the total blood test at the screening not higher/lower than 1.1 x LLN/ULN (upper/lower limit of the normal reference range) *;
- •* normal reference values of the laboratory performing the studies must be provided before the volunteer screening begins
- •according to the biochemical blood test at the screening: the level of urea, creatinine, alanine aminotransferase, aspartate aminotransferase, glucose, creatine phosphokinase, total protein, bilirubin, glucose, LDH, alkaline phosphatase, LDL / HDL / VLDL - no higher/lower 1.1 X LLN/ULN (upper/lower limit of the normal reference range), total cholesterol level from 3,6 mmol/l to 7,8 mmol/l;
- •no changes in myocardium of inflammatory or dystrophic nature according to ECG results at screening;
- •lack of vaccination against influenza within 6 months before the start of the study (including during participation in other clinical trials).
排除标准
- •participation of a volunteer in any other study in the last 90 days;
- •any vaccination in the last 30 days;
- •vaccination against influenza within 6 months before the start of the study (including during participation in other clinical trials).
- •symptoms of respiratory illness in the last 3 days;
- •recent frequent nasal bleeding (> 5 last year);
- •chronic rhinitis, the presence of defects of the nasal septum, polyps of the nose or other significant anomalies;
- •surgical operations or a history of nasal trauma for 6 months.
- •treatment with steroids in the last 10 days;
- •administration of immunoglobulins or other blood products for the last 3 months;
- •taking immunosuppressive drugs and / or immunomodulators within 6 months before the start of the study;
- •regular past or current use of narcotic drugs;
- •pregnancy or breastfeeding;
- •systolic blood pressure less than 100 mmHg or higher than 139 mmHg; diastolic blood pressure less than 60 mmHg. or above 90 mmHg; the heart rate is less than 60 beats per minute or more than 90 beats per minute;
- •exacerbation of allergic diseases, the presence of anaphylactic reactions or angioedema in medical history;
- •hypersensitivity or allergic reactions to the administration of any vaccine in medical history;
- •allergic reactions to vaccine components;
- •diabetes mellitus or other forms of impaired glucose tolerance;
- •the presence of a concomitant disease that may influence the evaluation of the results of the study: active forms of tuberculosis, chronic liver and kidney diseases, severe thyroid dysfunction and other endocrine system diseases (diabetes mellitus), severe deseases of hematopoietic system, epilepsy and other CNS diseases, myocardial infarction, myocarditis, endocarditis, pericarditis, coronary heart disease, autoimmune pathology, serious chronic diseases requiring a hospitalisation;
- •donor blood donation (450 ml and more blood or plasma) less than 2 months before the start of the study;
- •taking a history of more than 5 units of alcohol (equal 0.25 liters of ethanol) per week;
- •smoking: more than 10 cigarettes a day;
- •planned hospitalization and / or surgical intervention during the study period, and 4 weeks before the expected date of vaccination.
研究组 & 干预措施
Stage 2 (Controll Group)
Placebo
干预措施: Placebo (Other)
Stage 2 Vaccine
The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose
干预措施: GamFluVac (Biological)
Stage 1 (GamFluVac with the help of a spray dispenser)
The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated intranasally with the help of a spray dispenser
干预措施: GamFluVac (Biological)
Stage 1 (GamFluVac intranasal drip)
The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated by intranasal drip
干预措施: GamFluVac (Biological)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: through the whole study, an average of 180 days
Determination of Number of Participants With Adverse Events
Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)
时间窗: through the whole study, an average of 90 days
Determination of antibody levels measured by an ELISA vs. baseline values and vs placebo
次要结局
- Assessment of antigen-specific cell-mediated immune response(at days 0 and 7)